Revofer 500 mg/10 ml (IV Injection or Infusion)

10 ml vial: ৳ 700.00

Medicine Details

Indications

  • Treatment of iron deficiency anaemia in adult patients
  • Intolerance to oral iron
  • Non-dialysis dependent chronic kidney disease

Description

  • Colloidal iron (III) hydroxide in complex with Carboxymaltose
  • Carbohydrate polymer that releases iron

Dosage & Administration

  • Stepwise approach
  • Determination of individual iron need based on body weight and haemoglobin (Hb) level
  • Calculation and administration of the iron dose(s)
  • Post-iron repletion assessments
  • Maximum individual iron dose(s) based on iron need
  • Administration by intravenous injection or infusion
  • Re-assessment by the clinician based on the individual patient's condition
  • Re-assessment of Hb level no earlier than 4 weeks post final administration

Interaction

  • No formal drug interaction studies performed

Contraindications

  • Hypersensitivity to active substance or any excipients
  • Serious hypersensitivity to other parenteral iron products
  • Anaemia not attributed to iron deficiency
  • Evidence of iron overload or disturbances in the utilisation of iron

Side Effects

  • Infrequent, usually mild and generally do not cause patients to stop treatment
  • Common: nausea, headache, dizziness, hypertension, injection site reactions
  • Uncommon: hypersensitivity, tachycardia, hypotension, flushing, dyspnoea, abdominal pain, constipation, diarrhea, Pruritus, urticaria, rash, myalgia, back pain, arthralgia, muscle spasms
  • Rare: anaphylactoid reactions, loss of consciousness, anxiety, phlebitis, syncope, bronchospasm, flatulence, angioedema, pallor, and face oedema, rigors, malaise, influenza like illness

Pregnancy & Lactation

  • No adequate and well-controlled trials in pregnant women
  • Benefit/risk evaluation required before use during pregnancy
  • Unlikely risk to breast-fed child based on limited data

Precautions & Warnings

  • Serious hypersensitivity reactions reported
  • Monitoring for signs and symptoms of hypersensitivity during and after administration
  • Hypertension: transient elevations in systolic blood pressure
  • Laboratory Test Alterations: overestimation of serum iron and transferrin bound iron by also measuring the iron in Revofer

Use in Special Populations

  • Single maximum daily injection dose of 200 mg iron not to be exceeded in haemodialysis-dependent chronic kidney disease patients
  • Not recommended in children under 14 years

Overdose Effects

  • Excessive dosages may lead to accumulation of iron in storage sites potentially leading to hemosiderosis
  • Monitoring of iron parameters such as serum ferritin and transferrin saturation may assist in recognizing iron accumulation

Therapeutic Class

  • Parenteral Iron Preparations

Storage Conditions

  • Cool and dry place below 30°C
  • Away from light
  • Do not freeze
  • Keep out of reach of children

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